Regulatory Affairs Sr. Associate

Toronto Area

• 2.5 years brand pharmaceutical regulatory experience• Led the preparation, submission, successful approval and launch of a high profile oncology priority review New Drug Submission• Responsible for Lifecycle management of a portfolio of products (S/NDS, Notifiable Changes, CTAs, and label review and changes)• Has covered different therapeutic areas, drug and medical devices (oncology, women’s health, hematology)• Demonstrated determination, research and communication skills shown in achieving agreement from Health Canada to make a product labeling change to overcome a long-standing marketing challenge. If communication with Health Canada was unsuccessful, other marketed products could have been negatively impacted. • Effective cross functional collaboration and communication with both internal (i.e. Medical, Marketing, MA, Legal, QA) and external (i.e. Health Canada/FDA) stakeholders• B.Sc in Life Sciences and Postgraduate certificate in Regulatory Affairs